Clearance Summary
NIKKISO PARALLEL FLOW DIALYZERS received FDA 510(k) clearance under submission number K801065, sponsored by Int'L Marketing & Sales Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1980-08-07.
- Submission: K801065
- Applicant / Sponsor: Int'L Marketing & Sales Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1980-08-07
Classification & Regulation
This clearance is catalogued under FDA product code FTG and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.